Cannabidiol compositions for the treatment of inflammation

ABSTRACT

The present invention includes composition and methods for treating inflammation and/or pain, the composition comprising: hemp cannabidiol (cannabinoid) 0.1%-0.6% weight percent; menthol 3.0-4.0% weight percent; arnica montana 0.1-5.0% weight percent; camphor 0.1-5.0% weight percent; bosweila serrata extract 0.1-5.0% weight percent; camphor terpene 0.1-5.0% weight percent; isopropyl alcohol &lt;30% weight percent; glycerin &lt;6.0% weight percent; and qs with water.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Ser.No. 62/876,143, filed Jul. 19, 2019, the entire contents of which areincorporated herein by reference.

TECHNICAL FIELD OF THE INVENTION

The present invention relates in general to the field of compositionsand methods for treating inflammation, and more particularly, tocompositions that include hemp oil cannabidiol to treat inflammation andpain related thereto.

STATEMENT OF FEDERALLY FUNDED RESEARCH

Not applicable.

BACKGROUND OF THE INVENTION

Without limiting the scope of the invention, its background is describedin connection with treatments for pain.

Presently, the over-use of oral over-the-counter Nonsteroidalanti-inflammatory drugs (NSAIDs), and the lack of available topicalover-the-counter pain relief alternatives has led to the need for newmethods and composition for treating inflammation and pain.

One such patent is U.S. Pat. No. 9,375,417, which relates to transdermalcannabinoid formulations that include tetrahydrocannabinol (THC), as anactive component to the formulation's effectiveness. The formulationstaught also include anti-convulsants, anti-psychotics, anti-oxidants,neuroprotective agents, anti-cancer agents, and have immunomodulatoryeffects.

U.S. Patent Publication US 2018/0284402A1 identifies severalformulations that contain Hemp Oil Cannabidiol with less than 0.3% TCH.Briefly, these applicants teach using cannabinoid compounds inhydrophilic compositions comprised of synthetic and natural plantextract compounds that are multifunctional TRPM8 ion channel agonists,TRPA1 and TRPV1 ion channel antagonists, CGRP antagonists, COX-2inhibitors and CB1 and CB2 antagonists. These applicants further teach atopical analgesic composition comprising at least one synthetic ornatural plant extract TRPM8 agonist, at least one synthetic or naturalplant extract that is a TRPA1 antagonist, and fixed plant seed oilcontaining Omega-3 fatty acids TRPV1 antagonists and a carrier.

What is needed are natural topical and analgesic pain relief and methodsto reduce neuropathic inflammatory pain.

SUMMARY OF THE INVENTION

In one embodiment, the present invention includes a compositioncomprising: hemp cannabidiol (cannabinoid); menthol; camphor; herbextract; and qs with water. In one aspect, the composition furthercomprises at least one of isopropyl alcohol, or propylene glycol. Inanother aspect, the composition further comprises at least deliveryvehicle or gel selected from: glycerin, Carbomer (polyacrylic acid),Hydrated Silica, Aminomethyl Propanol, or Methyl Paraben. In anotheraspect, the herb extract is selected from at least one of Arnica MontanaExtract, Camphor Terpene Extract, Bosweila Serrata Extract, UricariaTomentosa Extract, or ILEX Paraguariensis Leaf Extract. In anotheraspect, the composition further comprises one or more inactiveingredients selected from at least one of: Isopropyl Alcohol, PropyleneGlycol, Glycerin, Carbomer 940, Hydrated Silica, Aminomethyl Propanol orMethyl Paraben. In another aspect, the amount of menthol is 0.1-0.6weight percent. In another aspect, the amount of menthol is less than0.5 weight percent. In another aspect, the amount of menthol is about3.0 to 5.0 weight percent. In another aspect, the composition is definedfurther as comprising hemp cannabidiol (cannabinoid) 0.1-0.6 weightpercent; menthol 3.0-4.0 weight percent; arnica montana 0.1-5.0 weightpercent; camphor 0.1-5.0 weight percent; bosweila serrata extract0.1-5.0 weight percent; camphor terpene 0.1-5.0 weight percent;isopropyl alcohol <30 weight percent; glycerin <6.0 weight percent; andqs with water. In another aspect, the composition is free of anytetrahydrocannabinol.

In another embodiment, the present invention includes a compositionconsisting essentially of: hemp cannabidiol (cannabinoid) 0.1-0.6 weightpercent; menthol 3.0-4.0 weight percent; arnica montana 0.1-5.0 weightpercent; camphor 0.1-5.0 weight percent; bosweila serrata extract0.1-5.0 weight percent; camphor terpene 0.1-5.0 weight percent;isopropyl alcohol <30 weight percent; glycerin <6.0 weight percent; andqs with water. In another aspect, the hemp cannabidiol is 0.16-0.17weight percent. In another aspect, the composition is free of anytetrahydrocannabinol. In another aspect, the composition consists of:hemp cannabidiol (cannabinoid) 0.1-0.6 weight percent; menthol 3.0-4.0weight percent; arnica montana 0.1-5.0 weight percent; camphor 0.1-5.0weight percent; bosweila serrata extract 0.1-5.0 weight percent; camphorterpene 0.1-5.0 weight percent; isopropyl alcohol <30 weight percent;glycerin <6.0 weight percent; and qs with water.

In another embodiment, the present invention includes a method oftreating inflammation, pain, or both comprising: providing an amount ofa composition effective to reduce or eliminate inflammation, pain, orboth, wherein the composition comprises: hemp cannabidiol (cannabinoid);menthol; arnica montana; camphor; a herb extract; camphor terpene;glycerin; and qs with water to treat inflammation, pain, or both. In oneaspect, the composition further comprises at least one of isopropylalcohol, or propylene glycol. In another aspect, the composition furthercomprises at least delivery vehicle or gel selected from: glycerin,Carbomer (polyacrylic acid), Hydrated Silica, Aminomethyl Propanol, orMethyl Paraben. In another aspect, the herb extract is selected from atleast one of Arnica Montana Extract, Camphor Terpene Extract, BosweilaSerrata Extract, Uricaria Tomentosa Extract, or ILEX Paraguariensis LeafExtract. In another aspect, the composition further comprises one ormore inactive ingredients selected from at least one of: IsopropylAlcohol, Propylene Glycol, Glycerin, Carbomer 940, Hydrated Silica,Aminomethyl Propanol or Methyl Paraben. In another aspect, the amount ofmenthol is 0.1-0.6 weight percent. In another aspect, the amount ofmenthol is less than 0.5 weight percent. In another aspect, the amountof menthol is about 3.0 to 5.0 weight percent. In another aspect, thecomposition is defined further as comprising hemp cannabidiol(cannabinoid) 0.1-0.6 weight percent; menthol 3.0-4.0 weight percent;arnica montana 0.1-5.0 weight percent; camphor 0.1-5.0 weight percent;bosweila serrata extract 0.1-5.0 weight percent; camphor terpene 0.1-5.0weight percent; isopropyl alcohol <30 weight percent; glycerin <6.0weight percent; and qs with water. In another aspect, the composition isfree of any tetrahydrocannabinol.

BRIEF DESCRIPTION OF THE DRAWINGS

Not applicable.

DETAILED DESCRIPTION OF THE INVENTION

While the making and using of various embodiments of the presentinvention are discussed in detail below, it should be appreciated thatthe present invention provides many applicable inventive concepts thatcan be embodied in a wide variety of specific contexts. The specificembodiments discussed herein are merely illustrative of specific ways tomake and use the invention and do not delimit the scope of theinvention.

To facilitate the understanding of this invention, a number of terms aredefined below. Terms defined herein have meanings as commonly understoodby a person of ordinary skill in the areas relevant to the presentinvention. Terms such as “a”, “an” and “the” are not intended to referto only a singular entity, but include the general class of which aspecific example may be used for illustration. The terminology herein isused to describe specific embodiments of the invention, but their usagedoes not limit the invention, except as outlined in the claims.

In another embodiment, the present invention includes a compositioncomprising two main active components, (1) Hemp Cannabidiol (0-THC) 500mg (Tested 99% purity) (0.1-0.6%); and (2) Menthol 3.0-4.0% (3.5%). Thecomposition may also include herbal extracts, including: (1) ArnicaMontana; (2) Camphor Terpene; (3) Bosweila Serrata Extract; (4) UricariaTomentosa Extract; and/or (5) ILEX Paraguariensis Leaf Extract. Further,the composition can include one or more inactive components, such as:Water, Isopropyl Alcohol; Propylene Glycol; Glycerin; Carbomer 940;Hydrated Silica; Aminomethyl Propanol; and/or Methyl Paraben.

In another embodiment, the present invention includes a compositioncomprising: at least two active ingredients, and two alcohols: isopropylalcohol, propylene glycol, agents comprising the delivery vehicle orgel: Glycerin, Carbomer (polyacrylic acid), Hydrated Silica, AminomethylPropanol, and Methyl Paraben. The active ingredients are: (1) HempCannabidiol (0-THC) 500 mg (Tested 99% purity) (0.1-0.6%); and (2)Menthol 3.0-4.0% (3.5%). The composition can also include certain herbalextracts (5.0%) that have been found to synergize with the two activeagents. These herbal extracts can include one or more of the following:(1) Arnica Montana; (2) Camphor Terpene; (3) Bosweila Serrata Extract;(4) Uricaria Tomentosa Extract; and/or (5) ILEX Paraguariensis LeafExtract. In certain embodiments, the composition includes 1, 2, 3, 4, orall 5 herbal extracts. The composition can also include one or more ofthe following inactive Ingredients: Water, Isopropyl Alcohol; PropyleneGlycol; Glycerin; Carbomer 940; Hydrated Silica; Aminomethyl Propanol;and/or Methyl Paraben.

The present invention shows the synergistic effects of Hemp Cannabidiolcombined with Menthol to provide clinically significant reductions inmusculoskeletal pain as compared to Hemp (0-THC) Cannabidiol, andMenthol alone. Current studies have revealed over 300 patientsexperiencing mild to severe pain benefited from the combination of Hempcannabidiol in menthol.

Cannabidiol is a hydrophobic compound that is absorbed better throughthe skin than it is absorbed through the gut. Topical application avoidsfirst pass liver metabolism, and irritation to the gut and GI lining.The formulation of the present invention was designed to be fast acting,long acting, dry quickly, and provide relief within seconds. Theinactive base formulation is designed to assist in absorption, dryingquickly with minimal residue, and scent.

The quick drying nature of the formulation allows it to be applied 10minutes prior to exercise to provider relief prior to perspiration. Thefast-acting nature of Menthol 3.5% in isopropyl alcohol providesimmediate relief. The inactive base formulation provides long actingeffects of menthol 3.5% localize to the skin with propylene glycol,carbomer, methyl paraben, hydrated silica, and glycerin.

The inactive base formulation adheres the formula to the skin such thatthe formulation stays in the applied area so that treatment andabsorption of Cannabidiol and Menthol can be absorbed into the targetarea.

Case Studies

Case #1: A 76 year old Caucasian male with a history of rheumatoidarthritis (RA), and debilitating joint pain. Had recent orthopedicspinal fusion of C3-C4 vertebrae to provide stability and subsequentmobility. The patient started on a regimen of OxyContin® 5 mg 3-5 timesa day as needed for pain for 3 days. The patient began with reporting apain score of 10 immediately post-op while taking prescription painmanagement medication. After day 3, the patient began using Cryogeltopically applied to the site of the pain 3-4 times a day. Cryogeltested was Hemp Cannabidiol (0-THC) 500 mg (Tested 99% purity)(0.1-0.6%), Menthol 3.0-4.0% (3.5%), Herbal Extracts (5.0%)(ArnicaMontana, Camphor Terpene, Bosweila Serrata Extract, Uricaria TomentosaExtract, and ILEX Paraguariensis Leaf Extract), inactive ingredients,and qs with water. Post-op pain begins to subside, and the patient wasable to discontinue opioid pain management, while continuing to use onlyCryogel topically. The patient 2 weeks post-op with 9 days of onlytopical Cryogel for 3-4 times daily is presenting with a pain score of2-3 with 1 being no-pain, and 10 being the most pain he's everexperienced.

Patient is currently reporting a pain score of 1-3. Patient reporting:“Questioned if I would ever reach this level following my last surgery.”“I still have discomfort, but mostly getting out of bed first thing inthe morning, and rising up from a soft low sofa.” “Your CBD product hasbeen tremendous.”

Case #2: A 66 year old Caucasian male with a history of injury, andexercise induced joint/muscle pain. Patient is very active, and an avidrunner. Patient begins experiencing chronic knee pain, and musclesoreness in late November 2018, and had tried the following with minimalrelief: Ibuprofen 200 mg: 4 TID with mild pain relief. Naproxen 375 mgER: 2 TID with mild pain relief. BIOFREEZE®: Applied topically to knee,and sore muscle. Patient began using Cryogel by applying the roll-onapplicator to the knees, and or sore muscles post exercise. The patienthas discontinued oral NSAIDs, and BIOFREEZE®, and has continued to useCryogel as the sole source pain relief applicator.

Patient has continued to use Cryogel, and has seen significant pain, andsoreness reduction to joints, and muscles. Patient reports applyingCryogel to joints and sore muscles as needed, and experience reliefwithin minutes. Patient also reports pain relief to last 4-6 hours.

Case #3: A 56 year old Female with a history of and exercise inducedjoint/muscle pain. Patient is very active, and an avid runner. Patientbegins experiencing chronic knee pain, and muscle soreness in lateJanuary 2019, and had tried the following with minimal relief:BIOFREEZE®: Applied topically to knee, and sore muscles 3-4 times day.Patient began using Cryogel by applying the roll-on applicator to theknees, and or sore muscles post exercise. The patient has discontinuedBIOFREEZE®, and has continued to use Cryogel as the sole source painrelief applicator. After 4 days, patient continued to use Cryogel, andhas seen significant pain, and soreness reduction to joints, andmuscles.

Patient reports applying Cryogel to joints and sore muscles as needed,and experience relief within minutes. Patient also reports pain reliefto last 4-6 hours.

Case #4: A 57 year old Male with a history of and exercise inducedjoint/muscle pain. Patient is very active: running, weightlifting,cycling, yoga. Patient begins experiencing chronic knee pain, and musclesoreness in late January 2019, and had tried the following with minimalrelief: Ibuprofen 200 mg: 2 Tablets as needed. BIOFREEZE®: Appliedtopically to knee, and sore muscles 3-4 times day. Patient began usingCryogel by applying the roll-on applicator to the knees, and or soremuscles post exercise. The patient has discontinued BIOFREEZE®, and hascontinued to use Cryogel as the sole source pain relief applicator.

Follow-up at three weeks. Patient has continued to use Cryogel, and hasseen significant pain, and soreness reduction to joints, and muscles.Patient reports applying Cryogel to joints and sore muscles as needed,and experience relief within minutes. Patient also reports pain reliefto last at least 4 hours.

Case #5: A 33 year old male presenting complaint sore/stiff neck lasting7 days. Patient is very active: running, weightlifting, cycling, yoga,swimming. Patient began experiencing neck and muscle soreness, after anupper extremity and shoulder workout on. Neck and muscle sorenessprohibited any physical activity. Patient began taking the followingthree days later with limited relief ALEVE® OTC Gel Caps: Take 2 GelCapsules 3-4 times daily. Patient also had deep muscle tissue massagethat provided minimal relief. Patient began using Cryogel five daysafter the injury, and began experiencing immediate relief. Patientreports pain, stiffness, and soreness resolved after 2 days of applyingCryogel 3-4 times daily. Follow-up two weeks later, patient reports nopain/soreness in neck, and is able to workout without fear or furtherinjury.

Case #6: A 29 year old female presenting complaint of sore back, andribs, after yoga workout. Patient is very active: running,weight-lifting, cycling, yoga, barre, kick-boxing. Patient beginsexperiencing back, and intercostal muscle soreness, shortly after apower yoga class Apr. 6, 2019. Patient began taking the following in anattempt to subside pain: ALEVE® OTC Gel Caps: Take 2 Gel Capsules 4times daily. Patient began using Cryogel four days after the start ofpain, and began experiencing immediate relief. Patient reports in upperback, and ribs resolved after 3 days of applying Cryogel 3-4 timesdaily. Follow-up 10 days later, patient reports no pain/soreness inback, and ribs and is able to resume intensive workouts without fear orfurther injury.

Case #7: A 46 year old male presenting with chronic lower back pain.Patient has history of RA, and has tried taking the following: Ibuprofen500 mg—Take 1 Tablet QID. Naproxen 375 ER—Take 1 Tablet QID.Hydrocodone/APAP 5 mg/500 mg—Take 1-2 Tablets 3-4 Times daily.BIOFREEZE®—Apply topically to affected area as needed. Tramadol 50mg—Take 1 Tablet TID. Tizanidine 4 mg—Take 1 Tablet BID. Patient hasexperienced limit pain relief. Patient presented to PCP requesting aHydrocodone/APAP 5 mg/500 mg refill. PCP provider initiated Cryogeltopically in office. Patient reported relief within a few minutes.Patient did not receive a refill for Hydrocodone/APAP 5 mg/500 mg.Patient purchased Cryogel, and has begun, a regimen of Cryogel, withIbuprofen PRN. Follow-up approximately one month later, patient reportsa significant reduction in pain score after initiating Cryogel. Patientwill occasionally take an over the counter NSAID if additional reliefneeded.

Case #8: A 66 year old male diabetic presenting with peripheralneuropathy. Patient experiences burning, stinging pain in feetassociated with peripheral neuropathy. Patient also has history ofarthritis, and has tried taking the following: Ibuprofen 500 mg—Take 1Tablet QID. LYRICA® 100 mg—Take 2-3 capsules as needed BID. Patient hasexperienced limit pain relief. PCP provider initiated Cryogel topicallyin office. Patient reported relief within a few minutes. Patientpurchased Cryogel, and has begun, a regimen of Cryogel, with IbuprofenPRN. Patient applies Cryogel to feet 2-3 Times daily for peripheralneuropathic pain in feet. Patient reports a significant reduction instinging, burning, and discomfort after initiating Cryogel. Patient willoccasionally take an over the counter NSAID if additional relief neededfor RA.

Case #9: A 56 year old female presenting with quad pain associated withexercise. Patient experiences burning, and soreness in right quad.Patient reported trying the following to relieve soreness and pain: SoftTissue Massage—provided limited relief. Topical CBD Oil (local shop handcrafted)—No relief. cbdMD-brand Topical Roll on—no relief. CBD OralTincture 100 mg—no relief. Ibuprofen 200 mg—Take 2 tablets TID—norelief. Patient began applying Cryogel to quad area of muscle injury ortear, and begins experiencing relief within a few hours. Patient reportsresolution of pain, and soreness after initiating Cryogel. Patientcontinues to use Cryogel as needed.

Case #10: Cryogel CBD 500 mg is a topical hemp applicator designed toassist in relieving joint, muscle, and arthritic aches and pains. 37 y/omale presenting with diagnosed, “Tennis Elbow,” of the right elbow.Patient experiences burning, and soreness in right elbow, and shootingpain down the right arm. Patient reported trying the following torelieve soreness and pain: Soft Tissue Massage—Providing Limited Relief.CBDMD Topical Roll on—No relief. Ibuprofen 200 mg—Take 2 tablets TID—Norelief. Patient began applying Cryogel to right elbow of injury or tear,and begin experiencing relief within a few hours. 5 days later. Patientreports resolution of pain, and soreness after initiating Cryogel.Patient continues to use Cryogel as needed.

Case #11: Cryogel CBD 500mg is a topical hemp applicator designed toassist in relieving joint, muscle, and arthritic aches and pains. 34 y/omale presenting with upper left trapezius muscle pain. Patientexperiences burning, tightness, soreness to left shoulder, and upperback. Patient reported trying the following to relieve soreness andpain: Soft Tissue Massage—Providing Limited Relief. Menthol10%—(BENGAY®)—No relief Ibuprofen 200 mg—Take 2 tablets TID—No relief.Patient began applying Cryogel to trapezius muscle of injury or tear,and begin experiencing relief within a few hours. 2 days later. Patientreports resolution of pain, and soreness after initiating Cryogel.Patient continues to use Cryogel as needed.

Case #12: Cryogel CBD 500 mg is a topical hemp applicator designed toassist in relieving joint, muscle, and arthritic aches and pains. 30 y/ofemale presenting with neck and shoulder muscle pain. Patientexperiences burning, tightness, soreness to left shoulder, and upperback. Patient reported trying the following to relieve soreness andpain: Soft Tissue Massage—Providing Limited Relief. Menthol10%—(BENGAY®)—No relief. CBDMD 750 mg CBD Roll on—No relief. Patientbegan applying Cryogel to muscle of injury or tear, and beginexperiencing relief within a few hours. 1 day later. Patient reportsresolution of pain, and soreness after initiating Cryogel. Patientcontinues to use Cryogel as needed.

Case #13: Cryogel CBD 500 mg is a topical hemp applicator designed toassist in relieving joint, muscle, and arthritic aches and pains. 30 y/omale presenting with quadricep tear or strain and right leg muscle pain.Patient experiences burning, tightness, soreness to right quadricep.Patient reported trying the following to relieve soreness and pain:Naproxen 220 mg—Take 2 tablets TID—limited relief. Menthol10%—(BENGAY®)—No relief. Patient began applying Cryogel to muscle ofinjury or tear, and begin experiencing relief within a few hours. 3 dayslater. Patient reports resolution of pain, and soreness after initiatingCryogel. Patient continues to use Cryogel as needed.

Case #14: Cryogel CBD 500 mg is a topical hemp applicator designed toassist in relieving joint, muscle, and arthritic aches and pains. 30 y/ofemale presenting with right calf muscle pain. Patient experiencesburning, tightness, soreness to right quadricep. Patient reported tryingthe following to relieve soreness and pain: Ibuprofen 200 mg—Take 2tablets TID—limited relief. Menthol 10%—(BENGAY®)—No relief. Patientbegan applying Cryogel to muscle of injury or tear, and beganexperiencing relief within a few hours. One month later. Patient reportsresolution of pain, and soreness after initiating Cryogel. Patientcontinues to use Cryogel as needed.

Case #15: Cryogel CBD 500 mg is a topical hemp applicator designed toassist in relieving joint, muscle, and arthritic aches and pains. 30 y/omale presenting with ankle swelling, and soreness. Patient experiencesswelling, soreness, tenderness to touch. Patient reported trying thefollowing to relieve soreness and pain: Ibuprofen 200 mg—Take 2 tabletsTID—limited relief. Menthol 10%—(BENGAY®)—No relief. Patient beganapplying Cryogel to muscle of injury or tear, and began experiencingrelief within a few hours. One month later. Patient reports resolutionof pain, and soreness after initiating Cryogel. Patient continues to useCryogel as needed.

Case #16: Cryogel CBD 500 mg is a topical hemp applicator designed toassist in relieving joint, muscle, and arthritic aches and pains. 67 y/ofemale presenting with labrum tear post-surgical repair, pain andsoreness. Patient experiences swelling, soreness, tenderness to touch,lack of mobility. Patient reported trying the following to relievesoreness and pain: Percocet—Take 1 tablet 4-6 hours for severepain—moderate relief.

Ibuprofen 200 mg—Take 2 tablets BID—limited relief. Menthol10%—(BENGAY®)—No relief. Patient began applying Cryogel to affectedshoulder post-surgery, and began experiencing relief within a few hours.Patient began using Cryogel day 3 post-op surgery and discontinuedPercocet and Ibuprofen after day 3. Patient continued to use Cryogel 500mg topical roll on as mono-therapy in conjunction with physical therapywith sufficient pain relief. One week later. Patient reports resolutionof pain, and soreness after initiating Cryogel. Patient continues to useCryogel as needed.

Case #17: Cryogel CBD 500 mg is a topical hemp applicator designed toassist in relieving joint, muscle, and arthritic aches and pains. 63 y/ofemale presenting with sciatica nerve pain beginning in upper right hiparea. Patient experiences burning, soreness, stinging pain, andsleeplessness. Patient reported trying the following to relieve sorenessand pain: Ibuprofen 200 mg—Take 2 tablets TID—limited relief. Menthol10%-(BENGAY®)—No relief. Patient began applying Cryogel to muscle ofinjury or tear, and began experiencing relief within a few hours. Onemonth later. Patient reports resolution of pain, and soreness afterinitiating Cryogel. Patient continues to use Cryogel as needed.

Case #18: Cryogel CBD 500 mg is a topical hemp applicator designed toassist in relieving joint, muscle, and arthritic aches and pains. 63 y/ofemale presenting burning, stinging pain, and inflammation in upperright elbow. Patient reported trying the following to relieve sorenessand pain: Ibuprofen 200 mg—Take 2 tablets TID—limited reliefBIOFREEZE®—Roll on Gel—Applied 4-5 times to affected area daily—minorrelief. Menthol 10%-(BENGAY®)—No relief. Patient began applying Cryogelto muscle of injury or tear, and began experiencing relief within a fewhours. One month later. Patient reports resolution of pain, and sorenessafter initiating Cryogel. Patient continues to use Cryogel as needed.

Case #19: Cryogel CBD 500 mg is a topical hemp applicator designed toassist in relieving joint, muscle, and arthritic aches and pains. 39 y/omale presenting bilateral inflammation of the knees postexercise/running. Patient reported trying the following to relievesoreness and pain: Ibuprofen 200 mg—Take 2 tablets TID—limited relief.Tylenol 500 mg—Take 2 tablets BID—Limited relief. Celebrex 200 mg—Take 1capsule by mouth daily—Limited Relief. BIOFREEZE®—Roll on Gel—Applied4-5 times to affected area daily—minor relief. Menthol 10%—(BENGAY)—Norelief. Patient began applying Cryogel to muscle of injury or tear, andbegan experiencing relief within a few hours. 4 days later. Patientreports resolution of pain, and soreness after initiating Cryogel.Patient continues to use Cryogel as needed.

Case #20: Cryogel CBD 500 mg is a topical hemp applicator designed toassist in relieving joint, muscle, and arthritic aches and pains. 34 y/omale presenting inflammation of the right wrist due to possible sprain.Patient reported trying the following to relieve soreness and pain:BIOFREEZE®—Roll on Gel—Applied 4-5 times to affected area daily—minorrelief. CBDMD 750 mg CBD—Roll on Applicator—Applied 4-5 timesdaily—minor relief. Patient began applying Cryogel to muscle of injuryor tear, and began experiencing relief within a few hours. 3 days later.Patient reports resolution of pain, and soreness after initiatingCryogel. Patient continues to use Cryogel as needed.

Case #21: Cryogel CBD 500 mg is a topical hemp applicator designed toassist in relieving joint, muscle, and arthritic aches and pains. 65 y/omale presenting inflammation of the right knee. Patient reported tryingthe following to relieve soreness and pain: Applied ice, and alternatingwith heat to reduce swelling and pain. Ibuprofen 200 mg—Take 2 tabletsBID—Limited Relief. Tylenol 500 mg—Take 2 tablets BID—No relief. Patientbegan applying Cryogel to muscle of injury or tear, and beganexperiencing relief within a few hours. 4 days later. Patient reportsresolution of pain, and soreness after initiating Cryogel. Patientcontinues to use Cryogel as needed.

It is contemplated that any embodiment discussed in this specificationcan be implemented with respect to any method, kit, reagent, orcomposition of the invention, and vice versa. Furthermore, compositionsof the invention can be used to achieve methods of the invention.

It will be understood that particular embodiments described herein areshown by way of illustration and not as limitations of the invention.The principal features of this invention can be employed in variousembodiments without departing from the scope of the invention. Thoseskilled in the art will recognize, or be able to ascertain using no morethan routine experimentation, numerous equivalents to the specificprocedures described herein. Such equivalents are considered to bewithin the scope of this invention and are covered by the claims.

All publications and patent applications mentioned in the specificationare indicative of the level of skill of those skilled in the art towhich this invention pertains. All publications and patent applicationsare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

The use of the word “a” or “an” when used in conjunction with the term“comprising” in the claims and/or the specification may mean “one,” butit is also consistent with the meaning of “one or more,” “at least one,”and “one or more than one.” The use of the term “or” in the claims isused to mean “and/or” unless explicitly indicated to refer toalternatives only or the alternatives are mutually exclusive, althoughthe disclosure supports a definition that refers to only alternativesand “and/or.” Throughout this application, the term “about” is used toindicate that a value includes the inherent variation of error for thedevice, the method being employed to determine the value, or thevariation that exists among the study subjects.

As used in this specification and claim(s), the words “comprising” (andany form of comprising, such as “comprise” and “comprises”), “having”(and any form of having, such as “have” and “has”), “including” (and anyform of including, such as “includes” and “include”) or “containing”(and any form of containing, such as “contains” and “contain”) areinclusive or open-ended and do not exclude additional, unrecitedelements or method steps. In embodiments of any of the compositions andmethods provided herein, “comprising” may be replaced with “consistingessentially of” or “consisting of”. As used herein, the phrase“consisting essentially of” requires the specified integer(s) or stepsas well as those that do not materially affect the character or functionof the claimed invention. As used herein, the term “consisting” is usedto indicate the presence of the recited integer (e.g., a feature, anelement, a characteristic, a property, a method/process step or alimitation) or group of integers (e.g., feature(s), element(s),characteristic(s), property(ies), method/process steps or limitation(s))only.

The term “or combinations thereof” as used herein refers to allpermutations and combinations of the listed items preceding the term.For example, “A, B, C, or combinations thereof” is intended to includeat least one of: A, B, C, AB, AC, BC, or ABC, and if order is importantin a particular context, also BA, CA, CB, CBA, BCA, ACB, BAC, or CAB.Continuing with this example, expressly included are combinations thatcontain repeats of one or more item or term, such as BB, AAA, AB, BBC,AAABCCCC, CBBAAA, CABABB, and so forth. The skilled artisan willunderstand that typically there is no limit on the number of items orterms in any combination, unless otherwise apparent from the context.

As used herein, words of approximation such as, without limitation,“about”, “substantial” or “substantially” refers to a condition thatwhen so modified is understood to not necessarily be absolute or perfectbut would be considered close enough to those of ordinary skill in theart to warrant designating the condition as being present. The extent towhich the description may vary will depend on how great a change can beinstituted and still have one of ordinary skill in the art recognize themodified feature as still having the required characteristics andcapabilities of the unmodified feature. In general, but subject to thepreceding discussion, a numerical value herein that is modified by aword of approximation such as “about” may vary from the stated value byat least ±1, 2, 3, 4, 5, 6, 7, 10, 12 or 15%.

All of the compositions and/or methods disclosed and claimed herein canbe made and executed without undue experimentation in light of thepresent disclosure. While the compositions and methods of this inventionhave been described in terms of preferred embodiments, it will beapparent to those of skill in the art that variations may be applied tothe compositions and/or methods and in the steps or in the sequence ofsteps of the method described herein without departing from the concept,spirit and scope of the invention. All such similar substitutes andmodifications apparent to those skilled in the art are deemed to bewithin the spirit, scope and concept of the invention as defined by theappended claims.

To aid the Patent Office, and any readers of any patent issued on thisapplication in interpreting the claims appended hereto, applicants wishto note that they do not intend any of the appended claims to invokeparagraph 6 of 35 U.S.C. § 112, U.S.C. § 112 paragraph (f), orequivalent, as it exists on the date of filing hereof unless the words“means for” or “step for” are explicitly used in the particular claim.

For each of the claims, each dependent claim can depend both from theindependent claim and from each of the prior dependent claims for eachand every claim so long as the prior claim provides a proper antecedentbasis for a claim term or element.

What is claimed is:
 1. A composition comprising: hemp cannabidiol(cannabinoid); menthol; camphor; herb extract; and qs with water.
 2. Thecomposition of claim 1, further comprising at least one of isopropylalcohol, or propylene glycol.
 3. The composition of claim 1, furthercomprising at least delivery vehicle or gel selected from: glycerin,Carbomer (polyacrylic acid), Hydrated Silica, Aminomethyl Propanol, orMethyl Paraben.
 4. The composition of claim 1, wherein the herb extractis selected from at least one of Arnica Montana Extract, Camphor TerpeneExtract, Bosweila Serrata Extract, Uricaria Tomentosa Extract, or ILEXParaguariensis Leaf Extract.
 5. The composition of claim 1, furthercomprises one or more inactive ingredients selected from at least oneof: Isopropyl Alcohol, Propylene Glycol, Glycerin, Carbomer 940,Hydrated Silica, Aminomethyl Propanol or Methyl Paraben.
 6. Thecomposition of claim 1, wherein an amount of menthol is 0.1-0.6 weightpercent.
 7. The composition of claim 1, wherein an amount of menthol isless than 0.5 weight percent.
 8. The composition of claim 1, wherein anamount of menthol is about 3.0 to 5.0 weight percent.
 9. The compositionof claim 1, wherein the composition is defined further as comprisinghemp cannabidiol (cannabinoid) 0.1-0.6 weight percent; menthol 3.0-4.0weight percent; arnica montana 0.1-5.0 weight percent; camphor 0.1-5.0weight percent; bosweila serrata extract 0.1-5.0 weight percent; camphorterpene 0.1-5.0 weight percent; isopropyl alcohol <30 weight percent;glycerin <6.0 weight percent; and qs with water.
 10. The composition ofclaim 1, wherein the composition is free of any tetrahydrocannabinol.11. A composition consisting essentially of: hemp cannabidiol(cannabinoid) 0.1-0.6 weight percent; menthol 3.0-4.0 weight percent;arnica montana 0.1-5.0 weight percent; camphor 0.1-5.0 weight percent;bosweila serrata extract 0.1-5.0 weight percent; camphor terpene 0.1-5.0weight percent; isopropyl alcohol <30 weight percent; glycerin <6.0weight percent; and qs with water.
 12. The composition of claim 11,wherein the hemp cannabidiol is 0.16-0.17 weight percent.
 13. Thecomposition of claim 11, wherein the composition is free of anytetrahydrocannabinol.
 14. The composition of claim 11, whereincomposition consists of: hemp cannabidiol (cannabinoid) 0.1-0.6 weightpercent; menthol 3.0-4.0 weight percent; arnica montana 0.1-5.0 weightpercent; camphor 0.1-5.0 weight percent; bosweila serrata extract0.1-5.0 weight percent; camphor terpene 0.1-5.0 weight percent;isopropyl alcohol <30 weight percent; glycerin <6.0 weight percent; andqs with water.
 15. A method of treating inflammation, pain, or bothcomprising: providing an amount of a composition effective to reduce oreliminate inflammation, pain, or both, wherein the compositioncomprises: hemp cannabidiol (cannabinoid); menthol; arnica montana;camphor; a herb extract; camphor terpene; glycerin <6.0; and qs withwater, to treat inflammation, pain, or both.
 16. The method of claim 15,further comprising at least one of isopropyl alcohol, or propyleneglycol.
 17. The method of claim 15, further comprising at least deliveryvehicle or gel selected from: Glycerin, Carbomer (polyacrylic acid),Hydrated Silica, Aminomethyl Propanol, or Methyl Paraben .
 18. Themethod of claim 15, wherein the herb extract is selected from at leastone of Arnica Montana Extract, Camphor Terpene Extract, Bosweila SerrataExtract, Uricaria Tomentosa Extract, or ILEX Paraguariensis LeafExtract.
 19. The method of claim 15, further comprising one or moreinactive ingredients selected from at least one of: Water, IsopropylAlcohol, Propylene Glycol, Glycerin, Carbomer 940, Hydrated Silica,Aminomethyl Propanol or Methyl Paraben.
 20. The method of claim 15,wherein an amount of menthol is 0.1%-0.6 weight percent.
 21. The methodof claim 15, wherein an amount of menthol is less than 0.5 weightpercent.
 22. The method of claim 15, wherein an amount of menthol isabout 3.0 to 5.0 weight percent.
 23. The method of claim 15, wherein thecomposition comprises hemp cannabidiol (cannabinoid) 0.1-0.6 weightpercent; menthol 3.0-4.0% weight percent; arnica montana 0.1-5.0 weightpercent; camphor 0.1-5.0 weight percent; bosweila serrata extract0.1-5.0 weight percent; camphor terpene 0.1-5.0 weight percent;isopropyl alcohol <30 weight percent; glycerin <6.0 weight percent; andqs with water.